EP1825817B1 - Anchor element for knotless attachment of tissue to a bone - Google Patents

Description

The invention relates to an anchoring element for knot-free fixation of tissue to a bone by means of at least one thread threaded through the anchoring element, with a body on the outside of which protrusions are provided which prevent withdrawal of the anchoring element inserted in the bone, with one in the distal end region of the body arranged and passing therethrough transverse bore for threading the at least one thread across the body, and with a longitudinally movable body clamping member for clamping the durchgefädelten through the body thread, wherein the clamping element is disposed within the body and for clamping the thread in the direction the transverse bore is movable.

Such an anchor element is for example from the US 2004/0138706 A1 known.

Such anchoring elements, also called suture anchors, are used in the medical field to fix tissue detached from a bone, usually tendons, again on the bone.

In principle, the anchoring element together with a thread connected to the anchoring element is driven into the bone in a fixed manner. The protruding suture ends are connected to the detached tissue, thereby fixing the detached tissue to the bone.

At a first, in particular from the US 5,690,676 known surgical technique, the anchoring element is designed so that it has an approximately cylindrical body, on the outside of which projections are provided which prevent withdrawal of the anchor element after it has been introduced into the bone. These projections may be formed as a barb-like elements, for example, when the anchor element is hammered or driven into the bone or may also be formed as an external thread when the anchor element is screwed into the bone in the manner of a screw. The thread is threaded through the passing through the body transverse bore and the two thread ends are inserted during the driving in outer longitudinal grooves on the body and guided proximally. At the proximal end of the anchor element engages a so-called single-driver, which is usually placed on the proximal end of the anchor element. The two thread ends are guided along the driver and wound there on radially projecting pin for the driving operation.

After the anchor element has been driven into the bone and the driver has been removed, the two free thread ends serve to secure the detached tissue. For this purpose, the two ends of the thread with the detached tissue, for example with a tendon, tightly knotted adjacent to the bone.

The anchored in the bone anchoring element on the one hand and the node on the other hand form the force / abutment points, between which the tissue is fixed.

A disadvantage of this surgical technique is that the knot requires considerable experience and dexterity of the surgeon. Such nodes may detach, or, as the node must be introduced from the outside, soft tissue bridges may form.

In a further development of this surgical technique, so-called node-free anchors have been developed, as for example US 2004/0138706 A1 are known and are also the subject of the present invention.

Also in this surgical technique, the thread is first threaded through the anchor element. One of the free ends of the thread is pierced through the fabric to be fixed, usually with the aid of a needle, and the pierced end is again threaded through in the opposite direction through the transverse bore in the anchor element. The connection between anchor element and tissue to be fixed is in the form of a loop of thread. The anchor element can now be introduced into the bone together with the thread and it is then pulled to the free ends of the thread, whereby the projecting loop of the thread, which is connected to the tissue, is used at the point to be fixed.

To fix the relative position between the thread and the connected tissue and anchoring element no knot is now accomplished, but it is a clamping element moves, fixed by the thread in a certain position on the anchor element is said to be clamped. This will also fix the loop that holds the tissue. The protruding free ends can then be cut off, for example, and it is not necessary to attach a knot.

In the US 2004/0138706 A1 the clamping element is designed as a sleeve applied to the outside of the body of the anchor element. Sleeve and body are relatively displaceable.

In a sliding position of the sleeve of threaded through the body thread is free to move, for example, to use the pierced by the thread tissue to the bone and to determine its position. Subsequently, the sleeve is displaced to thereby jam the thread and fix it in its relative position.

Especially from the transition from FIG. 4 to FIG. 5 of the US 2004/0138706 A1 it can be seen, there are several relatively sharp-edged clamping points, between which the thread is crushed. As a result, relatively high shear forces occur, so that a violation of the thread and thus a tearing can not be ruled out with certainty.

In addition, the outer sleeve is a very complicated shaped component, which, for exerting a clamping force, must be slightly spread by the anchor element. For this purpose, appropriate latching transitions between the outside of the body of the anchor member and the inside of the sleeve are necessary to make it difficult to solve this locking position or impossible. Thus, corrections, for example, under a temporary release of the clamping connection, hardly or only difficult to perform.

It should be remembered that the dimensions of such clamping elements are in the range of lengths of a few centimeters and diameters of a few millimeters.

Therefore, not only the production of such parts is extremely expensive, but also their handling is very difficult and in particular their stability with respect to the holding or fixing force is extremely problematic.

If a highly stressed tendon, for example, from the shoulder area or the knee area, fixed, it is evident that significant tensile forces from the tendon on the bone introduced assembly of body, clamping element and intervening clamped thread act.

Considering the above-mentioned sizes, it is obvious that the wall thickness of the outer sleeve may be at most in the range of fractions of a millimeter, but just this component should provide the clamping force for holding the thread.

Since the sleeve by design occupies a certain proportion of the outside of the body of the anchor element, but this anchor element serves to hold on the outside of its projections on the outside all the assembly in the bone, appropriate design precautions must be taken so that the body of the anchor element as such can be safely anchored in the bone.

This now leads to further considerable design effort.

From the US 2005/0055052 A1 For example, a knot-free anchoring element is known which has an inner element arranged at a proximal end of the anchoring element. The inner element has two transverse bores for threading through surgical threads. Further, the anchor member is provided with an outer member formed as a sleeve, which also has transverse bores, and is slidably disposed on the inner member. In order to clamp the thread threaded through the transverse bores of the inner member in the transverse bores, first the outer member is attached to the inner member so that the transverse bores of the outer member and the inner member are in alignment. In this position, the thread is threaded through both the transverse bores of the inner and outer members. Then, the thread is clamped by axially displacing the outer member relative to the inner member between the inner and outer members.

From the US 5,464,427 is a spreadable suture anchor known. The thread anchor known from this document consists of a generally cylindrical base body and an approximately conical body. The approximately conical body is inserted with its tapering end in a longitudinally extending slot of the base body, whereby a spread of the latter is effected. The spread of the suture anchor leads to an improved fixation of the anchor in the bone mass.

From the above US 2005/0245932 A1 anchoring elements are known which serve for knot-free fixation of tissue to a bone by means of a threaded through the anchor element thread. The known, in particular in Fig. 14 A, B to 17 A, B illustrated anchor elements each have a passing through the anchor element transverse bore, which serves for threading at least one surgical thread across the anchor element. Further, in the known anchor elements, an approximately disc-shaped clamping element is provided, which serves for clamping the thread, which is threaded through the transverse bore. In order to clamp the thread in the transverse bore of the anchor element, the disk-shaped clamping element is driven into a longitudinal bore in the anchor element, which opens into the transverse bore, and moved in the direction of the transverse bore.

This document discloses the preamble of claim 1.

It is an object of the present invention to provide an anchor element of the type mentioned, which is simple in construction, ensures an effective anchoring of the anchor element and at the same time allows an effective and damage-free fixation of the thread.

According to the invention, the object is achieved, on the one hand, in that the entire clamping element arranged inside the body is designed as a pin which can be moved in and out along a longitudinal axis of the body in the direction of the transverse bore, and in that the clamping element can be fixed in the body via a thread is.

According to the invention, the object is achieved, on the other hand, in that the entire clamping element arranged inside the body is designed as a pin, which can be moved in and out along a longitudinal axis of the body in the direction of the transverse bore, and in that the clamping element is designed as a conical element.

A considerable advantage of the measure of the formation of the arranged inside the body portion of the anchor element as a pin is that this geometry allows a compact, stable clamping element, which, even with very small overall sizes of the anchor element, can transmit the necessary clamping force.

The measure of arranging a portion of the displaceable clamping element inside the body has the advantage that the outside of the body is not occupied by this clamping element, so that the outside the body of the clamping element is fully available for anchoring to the bone. If the portion of the clamping element arranged in the interior is moved away from the transverse bore, the thread threaded through the transverse bore can be moved freely. By moving the inner portion of the clamping element in the direction of the transverse bore now recorded in the transverse bore portion of the thread can be clamped.

This can be done directly by the clamping element itself or the clamping element can squeeze another element, such as a recorded in the transverse bore clamping aid. Since the outer side of the anchor element does not have to be occupied during these movements, these manipulations can be carried out inside the body after the anchor element has already been driven in the bone. As a result, for example, corrections of the thread seat with already introduced anchor element are possible without the anchor element has to be moved as such relative to the bone.

The handling of the clamping element in the interior of the body can be accomplished from the proximal side of the anchor element, for which purpose the clamping element could also protrude on the proximal side. The body of the anchor element may, as far as its external design features are concerned, be constructed in the same way as an anchor element that works with the knot. It must be provided only in the interior of the body, a corresponding cavity or bore, which is very easy to accomplish, in which the inner portion of the clamping element can be introduced. This inner portion can then be designed correspondingly solid in order to exercise the sufficient clamping force on the recorded in the transverse bore thread.

As an abutment for the clamping by the clamping element, the already existing inner wall of the transverse bore is available. This wall provides the thread with a sufficiently large contact surface available at which the thread to be clamped can be created or fixed by the displaced clamping element. In other words, the thread may jamming against the inner wall Apply the cross hole, so that the clamping forces are distributed over a relatively large area, so that the risk of injury and shearing the thread is greatly reduced.

The measure that the clamping element is disposed within the body, shows the advantage that the outer contour of the anchor element is in no way affected by the provision of the clamping element, that is, the entire outer contour of the anchor element can for the actual function, namely for anchoring in the bone, be used. Seen from the outside, an anchor element according to the invention can look structurally the same as, for example, from the US 5,690,676 known anchoring element, which is used in the art with the Verknstellung the knot. Here there is already sufficient experience of the constructive configurations in order to provide sufficient anchoring force, so that recourse is made to this wealth of experience.

The measure that the clamping element is formed as a conical element, has the advantage that such an element is very easy to manufacture and must be driven to fix the thread only inside the body. By appropriate selection of the cone angle and the length of the inner portion, the sufficient holding force or clamping force can be exercised.

Thus, the task is completely solved.

In a further embodiment of the invention, the pin is designed as a grub screw.

This measure has the advantage that a very compact and easy-to-control clamping element is present, which can be moved back and forth by simply rotating in accordance with the body of the anchor element.

In a further embodiment of the invention, a distal end of the clamping element is rounded.

This measure has the advantage that the aforementioned pressing or pressing of the thread in the transverse opening can be exercised with low shear and without damaging the thread.

In a further embodiment of the invention, the clamping element on a mounting feature on which a tool of a driver for the anchor element can be attached.

This measure now has the considerable advantage that at the same time the clamping element can be controlled with the same tool with which the anchor element is driven, that can be moved to clamp the thread in the direction of the transverse bore.

This measure has the advantage in terms of production and handling that not two tools need to be provided, one for driving the armature and one for moving the clamping element. The setting of the anchor element and the displacement of the clamping element can be performed in a single operation with a tool.

This is particularly helpful for the surgeon and promotes this surgical technique.

The materials used for the components may be metallic materials, especially titanium, as desired, or they may be made of resorbable materials, if desired.

It is understood that the features mentioned above and those yet to be explained below can be used not only in the specified combinations but also in other combinations or alone, without departing from the scope of the present invention.

The invention will be described in more detail below with reference to some selected embodiments in conjunction with the accompanying drawings and explained.

Figur 1

eine Explosionsdarstellung eines erfindungsgemäßen Ankerelements und dessen Klemmelements, wobei am unteren Ende das Handhabungswerkzeug zum Setzen des Ankerelementes in den Knochen dargestellt ist,

Figur 2

einen Längsschnitt des Ankerelementes von Figur 1 mit eingesetztem Klemmelement, wobei das Handhabungswerkzeug angesetzt ist und ein Faden durch das Ankerelement hindurchgefädelt ist, der aber noch frei bewegbar ist,

Figur 3

eine Momentaufnahme der Operationstechnik zum Setzen des Ankerelementes, wobei der in Figur 2 dargestellte Zusammenbau ersichtlich ist, der durchgezogene Faden bereits mit einem Gewebe verbunden und wieder durch die Querbohrung hindurchgezogen wurde,

Figur 4

einen Schnitt nach Setzen des Ankerelementes und Fixieren der Sehne mittels des Fadens und Fixieren des Fadens mittels des Klemmelementes in dem Knochen, und

Figur 5

eine Explosionsdarstellung eines weiteren Ausführungsbeispiels eines erfindungsgemäßen Ankerelementes mit keilförmigem Klemmelement.

Show it:

FIG. 1

an exploded view of an anchor element according to the invention and the clamping member, wherein at the bottom of the handling tool for setting the anchor element is shown in the bone,

FIG. 2

a longitudinal section of the anchor element of FIG. 1 with inserted clamping element, wherein the handling tool is attached and a thread is threaded through the anchor element, but which is still freely movable,

FIG. 3

a snapshot of the surgical technique for setting the anchor element, wherein the in FIG. 2 assembly shown can be seen, the solid thread has already been connected to a tissue and pulled back through the transverse bore,

FIG. 4

a section after setting the anchor element and fixing the tendon by means of the thread and fixing the thread by means of the clamping element in the bone, and

FIG. 5

an exploded view of another embodiment of an anchor element according to the invention with wedge-shaped clamping element.

One in the FIGS. 1 to 4 illustrated anchor element is designated in its entirety by the reference numeral 10.

Anchor member 10 includes an elongated coarse cylindrical body 12 having protrusions 16-16 "protruding therethrough at its outer side 14. Projections 16-16" are formed as projecting annular flanges, each distally over approximately conically tapered portions to the next Go over the ring flange. A distal end portion 18 of the body 12 is provided with a rounded tip 20. A proximal end 22 is formed by the cross-sectional area of the last projection 16 "'.

In the distal end portion 18 of the body 12, a transverse bore 24 passing therethrough is arranged. From the mouth opening of the transverse bore 24 extend along the longitudinal axis 26 of the body 12, two diametrically opposed longitudinal grooves 25 which are in the projections 16 'to 16 "' are cut.

As is known, the transverse bore serves to a thread 60, as in FIG. 2 is shown threading through the body 12. The both sides of the transverse bore 24 protruding thread sections can in the longitudinal grooves 25th are inserted, so that these thread sections closely adjacent to the body 12 coming from the transverse bore 24 can be guided proximally.

In the middle of the body 12, an axial bore 28 is inserted from the proximal end (see FIG FIG. 2 ), which opens at the distal end in the transverse bore 24.

In the axial bore 28, an internal thread 30 is cut.

This axial bore 28 serves to receive a clamping element 32.

The clamping element 32 consists of a pin 34, on the outside of an external thread 36 is present, which meshes with the internal thread 30 of the axial bore 28.

At the proximal end of the pin 34 is a recess 38, provided here in the form of a diametrical incision, the meaning and purpose of which will be explained below. At the distal end 40, the clamping element 33 is provided with a rounding 42.

In FIG. 1 at the lower end a so-called single driver 50 is shown, with which the anchor element 10 is handled.

The driver 50 has a rod 52, from the distal end face 52 of which a tool 56 projects, which is designed such that it can be positively inserted into the recess 38 of the clamping element 32. The front side 54 of the driver 50 is further designed such that it can be applied to the proximal end 22 of the body 12 of the anchor element 10.

At an axial distance to its end face 54 of the driver 50 is provided with two diametrically projecting pins 58, 59, which serve to wind up the two projecting yarn ends. Proximalseitig the rod 52 does not end here in one represented handle over which the driver 50 can be grasped by the operator by hand.

In FIG. 2 Now, a situation is shown in which the clamping element 32 is received in the interior of the body 12, while the external thread 36 is screwed into the internal thread 30, to the extent that the performed by the transverse bore 24 thread 60 is freely movable, as by the double arrows is indicated.

The proximal end 22 of the body 12 is seated on the front side 54 of the driver 50, the tool 56 engages in the recess 38 of the clamping element 32 a.

As mentioned previously, the longitudinal grooves 25 on the outer side 14 of the body 12 serve to guide the yarn ends closely fitting proximally. Accordingly, 50 grooves 62 are cut in the rod 52 of the driver to guide these yarn ends to the diametrically projecting pins 58, 59 around which they are wound.

As in particular from the sectional view of FIG. 2 As can be seen, rotating the driver 50 about the longitudinal axis 26 of the assembly causes rotation of the clamping member 32 within the anchor member 10, thereby moving the clamping member 32 toward and into the transverse bore 24. In this case, the recorded in the transverse bore 24 portion of the thread 60 is placed by the rounding 42 to this opposite inner wall of the transverse bore 24 and clamped according to further driving.

Due to the round and smooth contouring of rounding 42 of the clamping element 32 and the corresponding contouring of the inner wall of the transverse bore 24, the clamping force can be distributed to the thread over a relatively large area, thereby squeezing or shearing the fixed thread 60 are avoided in the transverse bore 24 can.

From the sectional view of FIG. 2 It can be seen that the axial bore 28 on the distal side of the transverse bore 24 is continued in a kind of gentle depression 29, which approximately corresponds to the contour of the rounding 42, so that the thread 60 can be fixed particularly gently, but firmly between depression 29 and rounding 42 ,

How out FIG. 2 can be seen, the anchored to the end face 54 of the driver 50 anchor element 10 driven by this into a bone or be taken.

The length of the tool 56 and the depth of the recess 38 in the clamping element 32 are chosen so that there is no impairment of the clamping element 32, however, a sufficient engagement between these two components is ensured to subsequent rotation of the clamping member 32 for Bewerkstelligen the clamping operation to be able to effect.

In FIG. 3 is a snapshot of a surgical technique in which an inventive anchor element 10 is used, shown.

From a bone 70, a part of a tissue 74, for example a tendon, has detached, which is to be fixed again to the bone 70.

In the illustrated embodiment, an opening 72, for example a bore, whose inner diameter is slightly smaller than the outer diameter of the projections 16 of the body 12 of the anchor element 10 in the region of the detachment into the bone 70. The assembly of anchor element 10 with therein received clamping element 32nd and driver 50 is brought to the surgical site, and the suture 60 becomes as in FIG FIG. 2 once threaded through the transverse bore 24. One of the free ends is pierced, possibly with the aid of a needle, through a detached portion of the fabric 74, wherein FIG. 3 this puncture 76 is shown in section. The through The puncture 76 emerging thread section is again passed through the transverse bore 24, in the opposite direction as before.

This creates how that looks like FIG. 3 it can be seen, a loop 61, via which the fabric 74 is connected to the anchor member 10. The two free thread ends are now guided along the assembly of Eintreiber 50 and anchor member 10 close fitting to the pins 58, 59, and threaded around this.

Subsequently, the anchor element 10 is hammered into the opening 72 of the bone 70 by means of the driver 50. By pulling on the free ends of the thread 60, the detached tissue section 74 can be brought into the desired relative position to the bone or anchor element. By turning the driver 50, the clamping element 32 is now moved into the transverse bore 24 and clamps the two recorded in the transverse bore thread sections. The driver 50 is removed and the protruding thread sections can be separated.

Here it is quite possible to carry out certain corrections of the thread seat even when already set anchor element 10 by again the clamping element 32 is loosened somewhat. After removal of the driver 50 is the tissue to be fixed 74, as in FIG. 4 is shown again on the bone 70. Only the loop 61 of the thread 60 is visible, so there is no bulky node section. Inside the body 12, the recorded in the transverse bore 24 portions of the thread 16 are fixed in position by the screwed clamping element 32.

In FIG. 5 another embodiment of an anchor element is shown, which is designated in its entirety by the reference numeral 90. This anchor element 90 also has a body 92, on whose outer side 94 corresponding projections 96 are formed. Again, a transverse bore 98 is provided for the passage of the thread.

It is in the comparison to FIG. 1 It can be seen that the outer contour of the body 92 is the same as the outer contour of the body 12.

The axial bore 100 in the interior of the body 92 is designed as a conical bore, into which a clamping element 102 can be inserted, which has a corresponding cone 104.

Again, the clamping element 102 again has a rounded distal end 106.

The technique of setting the anchor element 90 is similar to the technique described above. For clamping the thread, however, here the clamping element 102 is hammered into the axial bore 100 by means of the driver and thereby accomplishes the clamping of the thread.

The cone angle is selected to be correspondingly small, so that no self-releasing effect, but the sufficient clamping or inhibiting effect is ensured when the clamping element 102 is taken.

The anchor element 90 may be made of bioresorbable materials, for example, which may also apply to the anchor element 10.

The anchor element 10 may also be made of metallic material, for example of titanium.

The length of such anchor elements is usually in the range between 3 and 6 centimeters, the diameter is in the range of a few millimeters to the range of about one centimeter. Even with non-metallic materials sufficient mechanical stability is present, both in terms of anchoring in the bone and as regards the fixation of threaded in the anchor element thread.

Claims (5)

1. An anchor element for knot-less fixing of a tissue (74) to a bone (70) by means of at least one suture (60) threaded through said anchor element (10), comprising a body (12) having projections (16 to 16"') projecting from its outer face (14) for preventing removal of said anchor element (10) when inserted in the bone (70), a transverse bore (24) arranged in a distal end section (18) of said body (12), said transverse bore (24) extending through said body (12), and serving for threading said at least one suture (60) transversely through said body (12), and comprising a clamping element (32) for clamping said suture (60) threaded through said body (12), wherein said clamping element (32) is arranged within said body (12), and is movable towards said transverse bore (24) for clamping said suture (60), characterized in that the whole clamping element (32) arranged inside said body (12) is designed as a pin (34) which is movable along a longitudinal axis (26) of said body (12) towards and into said transverse bore (24), and that the clamping element (32) is fixable via an external thread (36) in said body (12).
2. An anchor element for knot-less fixing of a tissue (74) to a bone (70) by means of at least one suture (60) threaded through said anchor element (90), comprising a body (92) having projections (96) projecting from its outer face (94) for preventing removal of said anchor element (90) when inserted in the bone (70), a transverse bore (98) arranged in a distal end section (18) of said body (92), said transverse bore (98) extending through said body (92), and serving for threading said at least one suture (60) transversely through said body (92), and comprising a clamping element (102) for clamping said suture (60) threaded through said body (92), wherein said clamping element (102) is arranged within said body (92), and is movable towards said transverse bore (98) for clamping said suture (60), characterized in that the whole clamping element (102) arranged inside said body (92) is designed as a pin (34) which is movable along a longitudinal axis (26) of said body (92) towards and into said transverse bore (98), and that the clamping element (102) is designed as a conical element (104).
3. The anchor element of claim 1, characterized in that said pin (34) is designed as a headless screw.
4. The anchor element of claims 1 to 3, characterized in that a distal end (40, 106) of said clamping element (32, 102) is rounded.
5. The anchor element of claims 1 to 4, characterized in that said clamping element (32, 102) comprises an assembly feature (38) onto which a tool (56) of a driver device (50) for said anchor element (10, 90) can be attached.

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